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Ken Peh ★ Malaysia, 2013-06-03 21:11 (4362 d 23:32 ago) Posting: # 10720 Views: 5,699 |
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Dear All, May I know how to calculate the 90% Confidence Interval (CI) for AUC and Cmax in a fully replicate design of 2x2x4 for highly variable drug ? We follow the progesterone method proposed by FDA and calculate to the last step of point estimate. However, we are not sure how to calculate the 90% CI. Your input is highly appreciated. Thank you. Regards, Ken Edit: Category changed. [Helmut] |
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jag009 ★★★ NJ, 2013-06-03 22:06 (4362 d 22:36 ago) @ Ken Peh Posting: # 10721 Views: 4,867 |
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Hi Ken, ❝ May I know how to calculate the 90% Confidence Interval (CI) for AUC and Cmax in a fully replicate design of 2x2x4 for highly variable drug ? We follow the progesterone method proposed by FDA and calculate to the last step of point estimate. However, we are not sure how to calculate the 90% CI. I tried the code and it worked(sample data). Did you check Helmut's post about the FDA progesterone guidance pdf having missing SAS codes(due to the font color or something)? John |
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Ken Peh ★ Malaysia, 2013-06-05 14:43 (4361 d 06:00 ago) @ jag009 Posting: # 10727 Views: 4,813 |
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Dear John, Maybe my question is not clear. Let me rephrase. Referring to the progesterone guidance, Step 1, if SWR ≥ 0.294, use the reference-scaled procedure to determine BE for the individual PK parameters. We follow the steps and calculate until Step 3a and b. Both Cmax and AUC pass. My question is : Do we stop here or we also need to calculate the 90% confidence interval for Cmax and AUC ? Step 3b is only point estimate. In the event we need to calculate the 90%CI, how to do it ?? Your feedback is highly appreciated. Thank you. Regards, Ken |
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Helmut ★★★   Vienna, Austria, 2013-06-05 15:40 (4361 d 05:03 ago) @ Ken Peh Posting: # 10729 Views: 4,840 |
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Hi Ken, ❝ […] We follow the steps and calculate until Step 3a and b. Both Cmax and AUC pass. ❝ ❝ My question is : ❝ Do we stop here Yes. That’s it. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Ken Peh ★ Malaysia, 2013-06-05 19:31 (4361 d 01:12 ago) @ Helmut Posting: # 10730 Views: 4,743 |
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Dear Helmut, Thank you very much. It clears our doubt. Will bring this up to the attention of our committee on BA/BE. Best Regards, Ken |
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jag009 ★★★ NJ, 2013-06-05 21:56 (4360 d 22:47 ago) @ Ken Peh Posting: # 10733 Views: 4,773 |
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Hi Ken, ❝ My question is : ❝ Do we stop here or we also need to calculate the 90% confidence interval for Cmax and AUC ? ❝ ❝ Step 3b is only point estimate. ❝ ❝ In the event we need to calculate the 90%CI, how to do it ?? Yes like Helmut said stop, present the ratio, 90% upper bound # to declare whether the result passes RSABE. However, if SWR<0.294 then you would do the 90CI (Average BE assessment, the regular test) using the PROC MIXED procedure attached in the progesterone guidance (I think at the last page of the guidance). John |
Ing. Helmut Schütz